GCP Update for Vaccitech


Welcome to the course resources for the GCP Update Course. In the lesson linked at the bottom of this page you can find the course video.  If you were unable to attend on the day and need a certificate you will be able to download your certificate once you have viewed the video and marked the lesson as complete .


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Course Handout

GCP Update 0821 ho

Useful Links

EU Clinical Trials Regulation

Eudralex Vol 10 – here you can find all the legislation and guidance for Clinical Trials in the EU


MHRA GCP forum – lots of useful information and examples

MHRA risk assessment examples

MHRA Inspection Metrics 2017-2018

MHRA Inspection Metrics 2018-2019

MHRA Guidance on responding to Inspection findings

MHRA Infringement Notice: Freelance monitor

MHRA Infringement notice: Investigator

MHRA Serious Breaches Guidance

MHRA Guidance on Access to Electronic Health Records

HRA Page on combined approval in the UK

UK SI 2004 1031 – Medicines for Human Use (Clinical Trials) Regulations

UK SI 2006 1928 – Medicines for Human Use (Clinical Trials) Amendment Regulations

Q&A on Reference Safety Information

EMA training on the Clinical Trials Regulation

Transcelerate Risk Based Monitoring Page – lots of information and tools

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